Replies to post #96697 on Avid Bioservices Inc (CDMO)

[volgoat]

TUSTIN, 9/24/12: Peregrine Pharmaceuticals (NASDAQ: PPHM) announced today that during the course of preparing for an end-of-phase II meeting with regulatory authorities and following recent data announcements from its randomized, double-blind placebo-controlled Phase II trial of bavituximab in second-line non-small cell lung cancer, it discovered major discrepancies between some patient sample test results and patient treatment code assignments.


This tells me that it is not all patients that were effected.

I am "assuming" sample test results were coded incorrectly, which could be mean a clerical error in the language used when coding.
They must all be consistent. Never do they mention that the drug was distributed incorrectly. (they just said the 3rd party was responsible for distribution and coding) and then mention a coding issue.

A 3mg dose would be noticeable compared to a 1mg dose and the docetaxel/placebo would be 75mg/2. no way did they mix up dosing IMO. The doctor/nurse administrating would know immediately based on volume and time to dose.

Could be as simple as coding a 1mg patient as a 3mg patient and having nothing to do with an incorrect dose.

We'll know soon enough, but I am starting to think this trial is salvaegble.

[Bungler]

Nuke,


You are absolutely correct that we are not familiar with the actual process of coding and distribution throughout the treatment cycles, nor do we have knowledge of exactly what happened, because we were not given that information; however I go back to my earlier observation that if you mess something up, you do not obtain good results. Look at the MOS results. If CSM was "randomly assigning drugs in a continuously varying manner" or an "intern running the coding and continuously screwing it up" would it be likely to see that kind of separation, or would you expect all three arms to come in about equal? Again, reminds me of the OJ Simpson trial. OJ's DNA matched the blood evidence from the crime scene - the defense argued that the police botched the handling of the blood evidence. If they botched it, then how would OJ's DNA match it, with a 10 billion to 1 odds that it could have come from someone else? If they botched it, then nobody's DNA should have matched it.